Kornimate/medical-research-clean huggingface dataset:
a study to evaluate rmc-035 in subjects undergoing cardiac surgery

Conditions: Acute Kidney Injury (AKI)

Summary: the purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of rmc-035 for the prevention and treatment of acute kidney injury (aki) in patients undergoing cardiac surgery.

this is a study with two parallel treatment groups where subjects are randomized to receive rmc-035 or a matching placebo in a double-blind fashion. the study will comprise of a screening visit, followed by cabg and/or valve replacement on day 1, double-blind treatment period and a follow-up period up to day 30.

Eligibility criteria:
key inclusion criteria: * female and male subjects with an age ≥18 years * subject is scheduled for non-emergent (elective) cabg and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (cpb) * subject has at least one of the following risk factors for aki at screening: * history of lvef \<35% for at least 3 months prior to screening assessed by either echocardiography, cardiac mri or nuclear scan. * history of previous open chest cavity cardiac surgery with or without cpb * confirmed diagnosis of type 2 diabetes (t2dm) at least 3 months prior to screening and ongoing treatment with an approved anti-diabetic drug * age ≥70 years * documented history of heart failure nyha class ii or higher for at least 3 months or longer at screening * documented history of previous aki before date of screening independent of the etiology of aki * documented history of anemia with hemoglobin ≤ 11 g/dl (≤6.8 mmol/l) for at least 3 months prior to screening * documented history of albuminuria, defined as uacr \>30 mg/g or \> 30 mg/24 hour in a 24-hour urine collection. * egfr is ≤ 60 ml/min/1.73 m2 using the chronic kidney disease - epidemiology collaboration (ckd-epi) equation key exclusion criteria: * estimated glomerular filtration rate (egfr) is \<30 ml/min/1.73 m2 using the chronic kidney disease - epidemiology collaboration (ckd-epi) equation at screening or at baseline * subject has surgery scheduled to be performed without cpb ("off-pump") * subject has surgery scheduled for aortic dissection * subject is scheduled for cabg and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation * subject is scheduled to undergo trans catheter aortic valve implantation (tavi) or trans catheter aortic valve replacement (tavr), or single vessel off-pump surgeries or left ventricular device (lvad) implantation * subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, iabp, lvad, other forms of mechanical circulatory support (mcs) (note: the prophylactic insertion of an iabp preoperatively for reasons not related to existing lv pump function is not exclusionary)

Keywords: aki
sars-cov-2 antibodies following exposure to coronavirus disease 2019 (covid-19) and/or vaccination in nursing homes

Conditions: COVID-19 Infection

Summary: presence of sars-cov-2 antibodies following exposure to coronavirus disease 2019 (covid-19) and/or vaccination is a major indicator of immunization. few data exit about serology response in nursing homes (nhs), i.e. in the most vulnerable population for developing severe forms of the disease. residents and health professionals in 9 nursing homes (nhs) with sars-cov-2 antibodies detection after exposure (either covid-19 or vaccine) all biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. in addition all directors and physicians of these nhs accepted to participate in this study


Eligibility criteria:
inclusion criteria: for residents: * living in one of the 9 nursing homes that participate in this study * having a sars-cov-2 post vaccination serology. * having no objection for using the results of the serology for the purpose of this analysis for health professionals: * working in one of the 9 nursing homes that participate in this study, * having a sars-cov-2 post vaccination serology. * having no objection for using the results of the serology for the purpose of this analysis exclusion criteria: * none

Keywords: sars-cov-2 antibodies vaccination nursing homes
pelvic fractures in the elderly

Conditions: Pelvic Fracture

Summary: the aim of the project is to predict the patient under conservative therapy as a function of the patient classification of rommens and hofmann and other potential prognostic factors. a corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.


Eligibility criteria:
inclusion criteria: * pelvic fracture after low-energy trauma * treatment in the years 2006 to 2016 * patients equal to or older than 60 years exclusion criteria: * pelvic fracture after a high-energy space * pathological fracture in the area of a tumor or a bony metastasis * existence of a documented refusal
gastric cancer screening quality improvement system establishment

Conditions: Gastric Cancer; Gastritis, Atrophic; Intestinal Metaplasia

Summary: experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.

this study is an extension of quality assurance program in seoul national university hospital healthcare system gangnam center. this study is composed of four periods. first, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from march 2008 till february 2009 and from march 2013 till february 2014, when the levels of serum pepsinogen were achieved from the patients. in the second period from march 2015 till april 2015, quality assurance program will be activated. endoscopists will be educated on the kimura-takemoto classification for chronic atrophic gastritis. after that their diagnosis will be tested and they will have feedback and discussion all together. in this period, inter-observer agreement rate will be assessed serially. third, prospective trial will run from may 2015 till april 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until december 2020.

Eligibility criteria:
inclusion criteria: * patients who received endoscopy in seoul national university hospital healthcare system gangnam center from 2008 till 2020. exclusion criteria: * age \< 18 years * those who refused to be included in the research * history of gastric cancer * current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin * active/healing stage of gastric ulcer or gastric ulcer scar * active/healing stage of duodenal ulcer * history of previous surgical or endoscopic resection of stomach

Keywords: gastric cancer chronic atrophic gastritis intestinal metaplasia
cvd nutrition modules tailored to low literacy skills

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.

background: the study was part of an nhlbi initiative on "cvd nutrition education for low literacy skills". the initiative originated within the prevention and demonstration branch of the deca, was approved by the september 1988 national heart, lung, and blood advisory council, and released in july 1990. design narrative: the study had three phases. the goal of phase i was to develop two innovative care modules that used demographic, psycho-social, nutritional, and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills. counselor directed innovative care consisted of a structured assessment and intervention package of simply written, graphically-oriented printed materials to guide the patient and health counselor (nutritionist, health educator, nurse, or physician). computer assisted innovative care used a user-friendly, interactive, computer assisted program permitting more sophisticated tailoring to individual needs, conveying nutrition information in a vivid, understandable format, and extending the services of the health counselor. the investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies. reliable and valid assessments of readability and comprehension helped further refine the materials. in phase ii, a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care. subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups: innovative care-counselor directed, innovative care-computer assisted, standard care, and usual care for dietary treatment of cholesterol, obesity, and hypertension. standard care involved the same amount of time and health counselor exposure as innovative care, but used currently available materials. usual care patients were referred to their usual provider for treatment. after four months and again at one year, changes in lipids, blood pressure, and weight were assessed.. phase ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments, worksites, and churches. results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency, and county health departments to implement the interventions at the community level.

Eligibility criteria:
must have high cholesterol; low-literacy skills; must be patient at one of 9 community health centers recruited for study
comparison of postoperative pain with two different types of local anesthesia in surgery for a drooping eyelid

Conditions: Blepharoptosis

Summary: conjunctival mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques. the investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival mullerectomy for ptosis repair. patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. in addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * patient with ptosis that requires correction * patient is able to consent for themselves exclusion criteria: * patient unable to complete survey * patient had prior lid surgery * patient taking chronic pain medication

Keywords: conjunctival mullerectomy blepharoptosis ptosis surgery pain control
a clinical study to test the efficacy and safety of csl312 on catheter-associated blood clot formation in subjects with cancer who receive chemotherapy through a picc line

Conditions: PICC-associated Thrombosis

Summary: peripherally inserted central catheters (piccs) are commonly used in patients with cancer to administer chemotherapy and supportive care medication. however, piccs and other medical devices that come into contact with blood increase the risk of blood clots (thrombosis) inside the blood vessels. conventional blood thinners (anticoagulants) may reduce the risk of thrombosis but they also increase the risk of bleeding. csl312, a monoclonal antibody that inhibits the activated blood clotting factor 12 (fxiia) will be assessed for its potential to prevent thrombus formation in subjects with cancer at risk of picc-associated thrombosis.


Eligibility criteria:
inclusion criteria: * aged 18 years or older at the time of providing written informed consent * diagnosis of malignancy that requires placement of a picc within the next 3 weeks for administration of chemotherapy (picc anticipated to be required for at least 1 month) * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 \[oken et al, 1982\], and investigator's expectation that performance status will remain 0, 1, or 2 for the duration of the study exclusion criteria: * active bleeding or with a current clinically significant coagulopathy (eg, international normalized ratio \[inr\] \> 1.5) or clinically significant risk for bleeding (eg, recent intracranial hemorrhage or bleeding peptic ulcer within the last 4 weeks) * history of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin iii, protein c or s deficiency) * life expectancy less than study duration (110 days) * platelet count of \< 20 × 109/l on the day of dose 1 (day 1) or within 7 days before first dosing * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 * treatment with antiplatelet or anticoagulant medication, including thrombosis prophylaxis, within 10 days prior to insertion of the picc * chemotherapy regimen that would be expected to drop the platelet count to \< 20 × 109/l * chemotherapy regimen with heparin mixed into iv bags (eg, dalteparin 2500 iu/day) * difficult iv access that would prevent infusion of the ip * in situ central venous catheter (cvc) or picc in the 3 months before the screening visit. the study picc must be inserted in the contralateral side, which must be picc / cvc naïve * undergoing dialysis or have another inserted intravascular foreign surface device * serum aspartate aminotransferase (ast) and serum alanine aminotransferase (alt) ≥ 4 × upper limit of normal
analysis of eye tissue

Conditions: Eye Disease; Inflammation; Uveitis

Summary: the purpose of this investigation is to better understand the inflammatory process that occurs in uveitis (eye inflammation) through study of eye tissues. patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight. those who require cataract surgery or vitrectomy are eligible for this study. samples of eye tissue and fluid normally removed during standard surgical procedures for these conditions will be given to researchers instead of discarded, as is usually done. before surgery, patients will undergo routine preoperative tests, including chest x-ray, electrocardiogram, blood tests and urinalysis. they will also have an eye examination and photographs taken of the retina. other tests that may be performed include fluorescein angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of the eye; and a gallium scan to evaluate inflammation. immune cells in the blood and eye tissue will be compared and categorized by disease. the eye fluid will be examined for substances involved in the inflammatory process. these studies may provide information that will lead to improved methods of diagnosis and treatment.

the purpose of this project is to evaluate intra-ocular tissue such as iris or vitreous from uveitis patients in order to analyze the type and character of the inflammatory response. patients with a history of uveitis who require cataract surgery or vitreous surgery because of the clinical complications of inflammation, will be entered in this study. the lymphocyte subsets in the peripheral blood and ocular tissue will be compared and categorized by disease. the presence of soluble lymphokines in the intra-ocular fluid will be analyzed. long term cell cultures of vitreal cells will be attempted to define the t-cell receptors. in addition, a portion of iris tissue or vitreous cells will be frozen to establish a tissue library of uveitis.

Eligibility criteria:
patients of either sex will be admitted to this study. all patients should have a previous history of uveitis. the patient must have lenticular or vitreal opacities which are significantly impairing their vision and for which surgical removal of the opacity has a reasonable chance of improving the vision. patients should have vision of 20/80 or worse. patients may have any of the following syndromes: anterior uveitis, including hla-b27-associated iritis and juvenile rheumatoid arthritis, ocular sarcoid, intermediate uveitis and pars planitis, birdshot retinochoroidopathy, behcet's disease, vogt-koyanagi-harada's syndrome, sympathic ophthalmia and idiopathic posterior uveitis.

Keywords: ocular inflammatory disease cataracts vitrectomy extracapsular cataract surgery uveitis lenticular opacity vitreal opacity
clinical performance evaluation of aqt90 flex tni and tnt

Conditions: Myocardial Infarction

Summary: the aqt90 flex troponin i (tni) and troponin t (tnt) tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (mi) in point-of-care and laboratory settings. the purpose of the study is to establish the clinical performance of the aqt90 flex tni and tnt assays for both whole blood and plasma in the intended use population.


Eligibility criteria:
inclusion criteria: * subject is 21 years of age or older. * subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study. * subject is presenting to the ed with acute chest pain or equivalent ischemic symptoms suggestive of acs or mi (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope). exclusion criteria: * subject is pregnant or may be pregnant. * subject has an invalid written informed consent or has withdrawn consent.
comparing vision tests in a virtual reality headset to existing analogues

Conditions: Ptosis; Macular Degeneration; Ametropia

Summary: the purpose of this study is to compare the results of vision tests that are algorithmically derived and delivered through a virtual reality headset with those delivered through the existing technology standards (eg. humphrey for field tests). tests that the researchers will be conducting include vision field perimetry, amsler, acuity chart, contrast- sensitivity and currently used office tests.

virtual reality (vr) constructs a 3-d reality right in a headset and the researchers are studying with what degree of accuracy it can be use to recreate vision tests that are used by eye doctors to screen and diagnose patients. vr provides advantages that could be used to improve eye care once the technology is tested and compared to the currently used vision tests - such as limiting the costs, duration and tedium associated with existing forms of vision screening tests. by doing so, the researchers hope to expand access to eye care by lowering the cost burden associated with vision tests. in this study, the research team will have subjects go through the vr versions of the test that are used in practice, and analyze their results in comparison to one another. after informed consent is obtained, the research team will collect subject demographic information (date of birth, gender, ethnicity, race) and clinically relevant medical history. afterward, the research team will proceed to the virtual reality tests: vision field perimetry, amsler, snellen chart, contrast- sensitivity and currently used office tests. the participants will undergo all the tests, vr and non-vr, which will be delivered in a randomized order. the entire sequence will last 30 minutes to one hour for a single test. the vr component will last about 5 minutes, this being the only addition to the scheduled vision tests. the sequence of vr / non vr testing will be randomized. based on the previous studies that compared humphrey matrix visual field and swedish interactive algorithm, the effect size is determined to be at least 30 subjects, and the goal is to reach n=1,000 participants.

Eligibility criteria:
inclusion criteria: * male and female patients of any race who are at least 18 years of age and can understand and provide verbal and written informed consent are eligible for this study. exclusion criteria: * patients who have had intraocular surgery less than six months ago, * potential contraindication for visual field test that include anxiety disorder, pregnancy, seizure disorder,cardiac pacemaker or another implantable device, severe vertigo or balance issues.

Keywords: vision screening virtual reality field test visual acuity contrast sensitivity
to determine the food effect and bioavailability of three formulations of veliparib in subjects with solid tumors

Conditions: Solid Tumors

Summary: compare the bioavailability of three veliparib formulations in subjects with solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy. 2. in the opinion of the investigator, life expectancy is 12 weeks or greater. 3. subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (cns) disease progression as determined by computed tomography (ct) scan or magnetic resonance imaging (mri) within 21 days prior to the first dose of study drug. 4. subject has an eastern cooperative oncology group (ecog) performance score of 0 to 2. 5. subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range. exclusion criteria: 1. the subject is unable to swallow capsules or has nausea or vomiting. 2. female subject is pregnant or breast-feeding. 3. subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., crohn's disease, celiac disease, gastroparesis, short bowel syndrome). 4. history of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (ph) or absorption. 5. subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * known seizure disorder that is uncontrolled over the past month * active uncontrolled infection * unstable angina pectoris or cardiac arrhythmia * psychiatric illness/social situation that would limit compliance with study requirements

Keywords: solid tumors veliparib refractory relapsed